Biomarker Commons

FDA review periods are lengthening for IVD tests that utilize molecular biomarkers, and at a faster rate than for IVDs overall, one of the key findings in a new report published this month by Amplion Research.

“Approval and Market Trends for Biomarker-Based IVD Tests (2003-2012),” is a new research report that draws on detailed analyses of every IVD test cleared or approved by the FDA over the last decade. The report can be found at http://www.amplion.com.

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

Atherotech Diagnostics Lab, a leading clinical reference laboratory specializing in cardiometabolic testing and disease management solutions, recently launched the AspirinWorks® Test to complement its menu of cardiovascular disease risk assessment tests.

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, protein biomarker-based assay for appendicitis, recently announced the appointment of Stephen A. Williams , M.D., Ph.D., Chief Medical Officer at SomaLogic, to the Company's Board of Directors. Dr. Williams brings his experience in diagnostic imaging and biomarker discovery to the Venaxis Board.